Neural Stimulator Delivery via CT-Guided Surgical Guide

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Solution Overview

Problem

Current medical procedures for implanting neural stimulators at the sphenopalatine ganglion (SPG) face challenges in precision and safety, particularly for less-skilled surgeons, due to the complex anatomical structure of the greater palatine canal, which requires accurate navigation and minimally invasive techniques.

Innovation Solution

A system comprising an oral surgical guide generated from CT and intra-oral scan data, a steerable delivery guide, and a flexible neural stimulator implant, allowing for precise and safe deployment of the implant at the SPG without the need for extensive surgical incisions, using a combination of image-guided surgery and 3D printed guides to navigate the canal.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional surgical methods are used to implant neural stimulators at the SPG, then surgeons can perform the procedure, but precision and safety are compromised due to the complex anatomical structure of the greater palatine canal

Engineering Contradiction:
Improveprecision of implant placementVSAvoidcomplexity of navigation required
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The surgical guide is fabricated before the surgery based on pre-operative CT scans and intra-oral impressions. The guide incorporates a guide hole pre-positioned to align with the greater palatine foramen, eliminating the need for intraoperative navigation and ensuring precise implant placement without requiring complex real-time navigation systems during the procedure.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The surgical guide acts as an intermediary device between the surgeon and the complex anatomical structure of the greater palatine canal. It translates pre-operative imaging data into physical guidance during surgery, simplifying the navigation task by providing a pre-defined access path through the guide hole that automatically aligns with the target location at the SPG.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If minimally invasive techniques are used to navigate the greater palatine canal, then safety is improved, but the ability to accurately navigate the complex anatomical structure becomes more difficult

Engineering Contradiction:
Improvesafety of procedureVSAvoidease of navigation
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The optimal navigation path is determined and physically embodied in the surgical guide before surgery. The guide hole is precisely positioned and oriented based on pre-operative imaging, allowing the surgeon to simply follow the pre-planned path without requiring complex intraoperative navigation skills or equipment, thereby maintaining safety while simplifying the operation.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The complex mechanical task of navigating through the curved greater palatine canal is replaced by a simple insertion through the guide hole. The surgical guide converts the complex 3D navigation problem into a simple linear insertion task, where the guide hole's geometry automatically provides the correct trajectory, reducing the skill requirement while maintaining safety.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Ease of manufacture

If extensive surgical incisions are made to access the SPG, then the implant can be deployed, but the invasiveness of the procedure increases

Engineering Contradiction:
Improveease of implant deploymentVSAvoidinvasiveness of procedure
Core Design Contradiction:
Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The surgical guide extracts and isolates the specific access path to the greater palatine foramen from the surrounding anatomy. By creating a dedicated guide hole at the precise location, it enables access through a minimal incision, eliminating the need for extensive surgical exposure while still allowing successful deployment of the neural stimulator implant.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The surgical guide provides localized access exactly where needed at the greater palatine foramen. The guide hole is positioned with precision to match the target anatomy, allowing the surgeon to make a small, localized incision rather than a large incision, thereby reducing tissue trauma while maintaining the ability to deploy the implant effectively.

Inventive Principle:
Principle #3Local quality

Data Source

PatentUS10512771B2Implant and delivery system for neural stimulator
Publication Date: 2019.12.24 BRAINSGATE LTD
  • US10512771B2 patent drawing
  • US10512771B2 patent drawing
  • US10512771B2 patent drawing

AI summary

Apparatus is provided for delivery of an implantable neural stimulator to a sphenopalatine ganglion (SPG) of a subject. The apparatus includes a tool having a proximal portion and having a distal portion coupled to the implantable neural stimulator; and a slide-bar at the proximal portion of the tool. The slide-bar includes a distal portion and a proximal portion. The proximal portion of the slide-bar is coupled to the stimulator such that distal advancement of the proximal portion of the slide-bar produces distal advancement of the stimulator. The proximal and distal portions of the slide-bar include respective magnetic coupling elements. The magnetic coupling elements are configured to couple the proximal and distal portions of the slide-bar to each other unless a distally-directed force applied to the distal portion of the slide-bar exceeds a threshold. Other embodiments are also described.